Objectives To describe the long-term efficacy and types of adverse events (AEs) in rheumatoid arthritis (RA) patients treated with etanercept in a daily clinical setting in Belgium.
Methods A prospective, multi-center, open-label, observational study in patients with active RA, who have previously failed 2 disease-modifying anti-rheumatic drugs (DMARD’s), one of which being methotrexate (MTX). Patients were treated with etanercept 25 mg subcutaneously twice a week or 50 mg OW, Health Assessment Questionnaire (HAQ-DI) was completed, swollen joint count was made, and adverse events (AEs) occurring during the previous period were registered.
Results Demographics and disease characteristics of 1596 patients are listed in table 1. 1596 patients were treated with etanercept, representing a total of 4461 Patient-Years. Patients were followed for at least 1 year and a maximum of 5.5 years. 730 patients discontinued treatment. The main reason (out of 6) for discontinuation was non-response (primary and secondary, at the discretion of the treating physician) (n=276). The other 2 main reasons are safety (n=227) and loss to follow-up (n=95). 878 (56.87%) patients reported adverse events of which 788 events were related to the treatment. 246 (15.93%) patients reported a serious adverse event (death, life-threatening, hospitalization, persistent disability, congenital anomaly or birth defect, pregnancy, overdose, abuse or new malignancy) of which 226 events are considered to be related to the treatment. Safety outcomes are listed in Table 2.
Infections were the most frequent AE’s. Injection site reactions were uncommon (n=46). No cases of tuberculosis were reported. Efficacy was evaluated by measuring number of joints with active synovitis and HAQ-DI. At baseline, the mean number of joints with active synovitis was 15.1±7.6. At month 6, the mean number of joints with active synovitis decreased to 4.0±5.4. At month 78, the mean number of joints with synovitis further decreased to 1.6±2.7. This represents a statistically significant decrease at both time points from baseline. At baseline, the mean HAQ-DI-score (/60) was 31.2±9.5. At month 6, the mean HAQ- DI score decreased to 15.9±11.3. At month 78, the HAQ-DI-score was 10.4±9.4. This represents a statistically significant decrease at both time points from baseline.
Conclusions This very first report with results from 1596 patients treated with etanercept in Belgium confirms the safety and efficacy profile in rheumatoid arthritis when used in daily clinical practice. No new safety signals were detected.
Disclosure of Interest C. Boone Employee of: Pfizer